Surrogate endpoints in trials: a call for better reporting

Ciani, O., Manyara, A. M. , Chen, A.-W. and Taylor, R. S. (2022) Surrogate endpoints in trials: a call for better reporting. Trials, 23, 991. (doi: 10.1186/s13063-022-06904-7) (PMID:36503559) (PMCID:PMC9743760)

Abstract

Using a surrogate endpoint as a substitute for a patient-relevant final outcome enables randomised controlled trials (RCTs) to be conducted more efficiently. However, the use of surrogates remains controversial and there is currently no guideline for the reporting of RCTs using surrogate endpoints; therefore, we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the reporting of these trials. We would like to invite interested individuals (trial methodologists, journal editors, healthcare industry, regulators and payers, and patient/public representative groups), particularly those with experience in the use of surrogate endpoints in trials.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Ciani, Professor Oriana and Manyara, Dr Anthony and Taylor, Professor Rod
• Authors: Ciani, O., Manyara, A. M., Chen, A.-W., and Taylor, R. S.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Trials
• Publisher: BioMed Central
• ISSN: 1745-6215
• ISSN (Online): 1745-6215
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in Trials 23: 991
• Publisher Policy: Reproduced under a Creative Commons License

Project Code	Award No	Project Name	Principal Investigator	Funder's Name	Funder Ref	Lead Dept
313399		Reporting of randomised trials using surrogate outcomes: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statements	Rodney Stephen Taylor	Medical Research Council (MRC)	MR/V038400/1	HW - MRC/CSO Social and Public Health Sciences Unit